C2C Development
Contract manufacturer and product development services provider focused on front-end medical device design, prototyping, pilot production, regulatory support and low-volume manufacturing under ISO 13485 and FDA registration. Offers design, process development, assembly, packaging, sterilization coordination, and verification/validation testing for less-invasive surgical devices and related markets.
Industries
Nr. of Employees
small (1-50)
C2C Development
Patents
Products
Tibial cement injection instrument (orthopedic device)
Design and manufacture of a tibial cement injection instrument; distributed to hospitals through orthopedic distributors.
Wound irrigation device (clinical irrigation device)
Design, development and pilot manufacture of a wound irrigation device developed with a hospital-foundry partnership for clinical evaluation.
Neurological and surgical device prototypes (portfolio examples)
Portfolio projects including prototypes and commercial versions for brain biopsy, deep brain stimulation, laser atherectomy and neurological drug delivery devices.
Tibial cement injection instrument (orthopedic device)
Design and manufacture of a tibial cement injection instrument; distributed to hospitals through orthopedic distributors.
Wound irrigation device (clinical irrigation device)
Design, development and pilot manufacture of a wound irrigation device developed with a hospital-foundry partnership for clinical evaluation.
Neurological and surgical device prototypes (portfolio examples)
Portfolio projects including prototypes and commercial versions for brain biopsy, deep brain stimulation, laser atherectomy and neurological drug delivery devices.
Services
Concept development, 3D modelling, rapid prototyping (3D printing, CNC) and iterative design testing for medical devices.
Manual and semi-automated assembly, component procurement, inspection, kitting, cleaning and pilot-scale production under controlled cleanroom conditions.
Consulting from initial regulatory planning through preparation and submission of regulatory documentation to assist in attaining clearances.
Protocol development, sample preparation, coordination with third-party sterilizers and laboratories, and final report generation.
Execution of packaging seal integrity, shelf-life, mechanical and functional tests to verify design and manufacturing outputs meet specifications.
Procurement and supplier qualification under an ISO 13485:2016 system to ensure materials and components are qualified and monitored.
Concept development, 3D modelling, rapid prototyping (3D printing, CNC) and iterative design testing for medical devices.
Manual and semi-automated assembly, component procurement, inspection, kitting, cleaning and pilot-scale production under controlled cleanroom conditions.
Consulting from initial regulatory planning through preparation and submission of regulatory documentation to assist in attaining clearances.
Protocol development, sample preparation, coordination with third-party sterilizers and laboratories, and final report generation.
Execution of packaging seal integrity, shelf-life, mechanical and functional tests to verify design and manufacturing outputs meet specifications.
Procurement and supplier qualification under an ISO 13485:2016 system to ensure materials and components are qualified and monitored.
Expertise Areas
- Medical device design and prototyping
- Low-volume and pilot manufacturing
- Process development and scale-up
- Regulatory strategy and submissions
Key Technologies
- 3D computer-aided design (CAD)
- Additive manufacturing (3D printing)
- CNC machining
- Nitinol shape-setting and thermal processing
News & Updates
Company operates under an ISO 13485:2016 certified quality management system.
Company is registered with the U.S. Food and Drug Administration as a medical device contract manufacturer.
Facility includes an ISO 7 (Class 10,000) certified cleanroom for device assembly and packaging.
Manufacture and distribution of a tibial cement injection instrument (orthopedic device) through a network of distributors and hospital use.
Company founder credited with over 100 issued U.S. patents.
Company operates under an ISO 13485:2016 certified quality management system.
Company is registered with the U.S. Food and Drug Administration as a medical device contract manufacturer.
Facility includes an ISO 7 (Class 10,000) certified cleanroom for device assembly and packaging.
Manufacture and distribution of a tibial cement injection instrument (orthopedic device) through a network of distributors and hospital use.
Company founder credited with over 100 issued U.S. patents.